FDA.reportPublic FDA data

Entacapone

Product NDC
65862-654
11-digit product format
658620654
Labeler code
65862
Product ID
65862-654_54466878-6cce-44e7-8188-27b6091a5d15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Entacapone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203437
Marketing category
ANDA
Marketing start
2015-06-19
Substance
ENTACAPONE
Active strength
200 mg/1
Pharmacologic classes
Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Entacapone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ENTACAPONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4975G9NM6T
Rxcui317094

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
6a098371-84f5-7ced-0ac5-ed90d535b476Product name620220927
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-654-01Entacapone100 in 1 BOTTLETABLET, FILM COATED1008
65862-654-99Entacapone1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-654-01EA - Each65862-6549feff485-3e39-4962-91df-1116387f430412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ENTACAPONEACTIVE INGREDIENT4975G9NM6TENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
ENTACAPONEACTIVE MOIETY4975G9NM6TENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-654ENTACAPONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20240510_d9cc1327-5474-4136-970a-ec40c41975b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317094entacapone 200 MG Oral TabletPSN3d4ec829-7835-4d59-bc5b-6ce38811fba78
317094entacapone 200 MG Oral TabletPSNd9cc1327-5474-4136-970a-ec40c41975b28
317094entacapone 200 MG Oral TabletSCD3d4ec829-7835-4d59-bc5b-6ce38811fba78
317094entacapone 200 MG Oral TabletSCDd9cc1327-5474-4136-970a-ec40c41975b28
317094entacapone 200 MG Oral TabletPSN1fab63f2-9257-6998-5658-7e98db51b1847
317094entacapone 200 MG Oral TabletSCD1fab63f2-9257-6998-5658-7e98db51b1847
317094entacapone 200 MG Oral TabletPSN863025af-2b71-477d-baa9-3ce7f435e3856
317094entacapone 200 MG Oral TabletSCD863025af-2b71-477d-baa9-3ce7f435e3856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-654-0165862065401100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01) 2015-06-190000-00-00NoNoCurrent
65862-654-99658620654991000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99) 2015-06-190000-00-00NoNoCurrent